Vigabatrin for Treatment of Cocaine Dependence

This study has been completed.

Sponsor:

Catalyst Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT00611130

First Posted: February 8, 2008

Last Update Posted: June 14, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Cocaine addiction, a serious public health concern associated with significant medical, social, and economic consequences, is difficult to treat using traditional psychosocial and behavioral therapies. Despite testing of a number of different agents for cocaine dependency, there remains no proven pharmacologic treatment for cocaine addiction.

The addictive properties of cocaine have been associated with its actions on mesotelencephalic dopamine reward pathways in the central nervous system (CNS). Cocaine administration increases the levels of dopamine, a neurotransmitter associated with sensations of pleasure and reward. Therefore, blocking cocaine-induced increases in dopamine levels represents a valid pharmaceutical approach to the treatment of cocaine addiction.

Another neurotransmitter, gamma-aminobutyric acid (GABA), suppresses striatal dopamine release, and attenuates cocaine-induced increases in extracellular and synaptic dopamine levels in the striatum and nucleus accumbens in animal models of drug dependence. Significant elevation of brain GABA levels may reduce cocaine-stimulated dopamine release and dampen the sensations of pleasure and reward. Thus, drugs that potentiate or enhance GABA-ergic transmission are candidates for the treatment of cocaine addiction.

Eligibility

Information from the National Library of Medicine

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Provide at least one urine sample that is positive for cocaine according to a rapid screening test.

Seeking treatment for cocaine dependence.

Have normal visual fields.

Be in generally good health based on history, physical examination, electrocardiogram and laboratory findings.

If female of childbearing potential, use acceptable contraceptive methods. (oral contraceptives (the pill), IUDs, contraceptive implants under the skin, contraceptive rings or patches or injections, diaphragms with spermicide, and condoms with spermicide). Surgical sterilization by tubal ligation or hysterectomy is acceptable

Exclusion Criteria:

Has current dependence, as determined by the SCID, on any psychoactive substance other than cocaine, alcohol, nicotine, or marijuana or physiologic dependence on alcohol requiring medical detoxification.

Has any serious medical or psychiatric illness and/or clinically significant abnormal laboratory value, which in the judgment of the Principal Investigator or his/her designee would make study participation unsafe, or would make treatment compliance difficult or put the study staff at undue risk.

Be under court mandate to obtain treatment.

Be enrolled in an opiate substitution treatment program within 2 months of randomization.

Has ever taken vigabatrin in the past.

Is pregnant or lactating.

Has clinically significant ophthalmologic disease, which would preclude safety monitoring or is undergoing treatment for ocular disease.

Has received a drug with known major organ toxicity, including retinotoxicity within 30 days of randomization.

Is currently participating in, or has been enrolled in another clinical trial within the last 30 days.

Be anyone who, in the judgment of the investigator, would not be expected to attend regular study visits or to complete the study protocol, due to imminent relocation from the clinic area, legal difficulties, work-related problems, transportation, etc.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00611130

Locations

United States, Arkansas

Addiction Treatment Clinic

Little Rock, Arkansas, United States

United States, California

St. Luke's Hospital Addiction Pharmacology Research Laboratory

San Francisco, California, United States, 94110

Friends Research Institute

Torrance, California, United States

United States, Florida

Operation PAR

Largo, Florida, United States

Segal Institute for Clinical Research

North Miami, Florida, United States, 33161

United States, Maryland

Johns Hopkins Bayview Medical Center Center for Chemical Dependence

Baltimore, Maryland, United States

United States, Massachusetts

Boston University School of Medicine

Boston, Massachusetts, United States

United States, New York

New York University Mental Health and Addictive Disorders Research Program